TYKERB Film-coated tablet Ref.[11065] Active ingredients: Lapatinib

Lapatinib is a small molecule and a member of the 4-anilinoquinazoline class of kinase inhibitors. It is present as the monohydrate of the ditosylate salt, with chemical name N-(3-chloro-4-{[(3-fluorophenyl)methyl]oxy}phenyl)6[5-({[2-(methylsulfonyl)ethyl]amino}methyl)-2-furanyl]-4-quinazolinamine bis(4-methylbenzenesulfonate) monohydrate. It has the molecular formula C₂₉H₂₆ClFN₄O₄S (C₇H₈O₃S)₂H₂O and a molecular weight of 943.5 g/mol.

Lapatinib ditosylate monohydrate has the following chemical structure:

Lapatinib is a yellow solid, and its solubility in water is 0.007 mg/mL and in 0.1N HCl is 0.001 mg/mL at 25°C.

Each 250 mg tablet of TYKERB contains 405 mg of lapatinib ditosylate monohydrate, equivalent to 398 mg of lapatinib ditosylate or 250 mg lapatinib free base.

The inactive ingredients of TYKERB are:

Tablet Core: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate.

Coating: Orange film-coat: FD&C yellow No. 6/sunset yellow FCF aluminum lake, hypromellose, macrogol/PEG 400, polysorbate 80, titanium dioxide.